Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22003
• EU PAS number:
  EUPAS22002
• Study ID:
  22003
• Official title and acronym:
  Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  United Kingdom
• Study description:
  This two-phase study aims to characterise the global practice of diagnosing interstitial lung disease (ILD) and identify the features of ILD multidisciplinary team (MDT) meetings associated with more accurate diagnosis of ILD. Phase I is a global, standardised, systematic evaluation of the diagnostic process employed by a range of dedicated and non-dedicated ILD centres worldwide. An electronic questionnaire will be distributed through local leads, and national and international consortia. A pragmatic “strategic-opportunistic” approach will be taken, combining easily-scalable electronic data capture with local expertise to invite responses from a wide and representative range of (ultimately self-selecting) clinics and centres.Phase II is a global MDT ILD case review and diagnosis study to assess the diagnostic agreement across ILD MDTs and assess the diagnostic accuracy of ILD MDTs. Appropriate definition of these Phase II design components will be critical to the robustness and relevance of the study. The Phase II definition of an MDT, and the study’s geographical scope and case mix distribution, will aim to reflect real-life (as far as is practically possible) as established in Phase I. Centres identified in phase I will be invited to participate. Participants will be sent digitised reference cases, including pathology data, and diagnostic responses will be collected. Diagnostic accuracy will be determined against the diagnosis given by the reference case provider, against an expert MDT with global representation, and where possible, against the diagnostic inference of available follow up data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 500 centres are involved in the study

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/08/2016

Actual: 01/08/2016

Study start date

Planned: 10/11/2016

Actual: 10/11/2016

Data analysis start date

Planned: 01/02/2017

Actual: 01/02/2017

Date of interim report, if expected

Planned: 01/12/2017

Actual: 01/03/2017

Date of final study report

Planned: 27/11/2017

Actual: 27/11/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Financial: Roche, Boehringer Ingelheim and Three Lakes Partnership, in kind: Veracyte

Study protocol

Initial protocol

GlobalILDEvaluation_Protocol060616

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

REG-RES1505